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VERIFICATION PROTOCOL OF PURE STEAM QUALITY

Equipment Name: Pure Steam Generator & Equipment No.: As per equipment ID
master list
Distribution System

Protocol No. Report No. Page No.

_____________________ ____________________ 1 of 24

Sr. No. ITEM DESCRIPTION PAGE NO.

1.0 PROTOCOL APPROVAL 2

2.0 OVERVIEW: 3

2.1 Objective 3

2.2 Purpose 3

2.3 Scope 3

2.4 Responsibility 3-4

2.5 Execution Team 5

3.0 GENERAL CONSIDERATION/PREREQUISITE 6

4.0 RE-VERIFICATION STUDY CRITERIA 6

5.0 SYSTEM & PROCESS DESCRIPTION 7

METHODOLOGY FOR VERIFICATION STUDY OF 8

6.0
STEAM QUALITY

6.1 Pure Steam Quality Test 8-14

7.0 ABBREVIATION 15

8.0 LIST OF ANNEXURES 16

9.0 DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S) 17

PERFORMANCE QUALIFICATION SUMMARY AND 18

10.0
CONCLUSION

10.1 Summary 18

10.2 Conclusion 18

11.0 FINAL REPORT APPROVAL: 19

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1.0 PROTOCOL APPROVAL:

Signing of this approval page of Protocol indicates agreement with the verification
study of pure steam quality described in this document. The protocol cannot be
used for execution unless approved by the following authorities.
Verification protocol of Pure steam quality has been reviewed and approved by
the following persons:

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

PREPARED QUALITY
BY ASSURANCE

QUALITY
ASSURANCE

ENGINEERING
REVIEWED
BY
QUALITY
CONTROL

PRODUCTION

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE
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2.0 OVERVIEW:
2.1 Objective:
The objective of this protocol is to develop a plan for verification of pure steam
quality throgh physical tests (Non codensable gas, Degree of super heat and
dryness fraction test), which is used to facilitate _____________manufacturing
facility.
2.2 Purpose:

The purpose of this protocol is to establish documentary evidence to ensure that

the pure steam quality meets the predetermined specification (As Per BS EN
285:1997), which is used for ______________ manufcturing facility.

2.3 Scope:
This protocol shall be used for the verification study of pure steam quality, which
is generated from pure steam generator (ID___________), installed in
________________ of _________ manufacturing facility, company
address__________as per SMF.
2.4 Responsibility:

In accordance with protocol, following functions shall be responsible for the

verification study of pure steam quality.

Execution Team (Comprising members from Engineering, Production and

Quality Assurance) and their responsibilities are following:
➢ Prepares verification study protocol.

➢ Distributes the finalized protocol for review and approval signatures.

➢ Execution of protocol.
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➢ Samling will be done by Engineering Persons.

Head– Engineering:
➢ Review of protocol, the completed qualification data package, and the final
report Approval.
➢ Assist in the resolving the validation deficiencies.
Head – Quality Control:
➢ Review of protocol, the completed qualification data package, and the final
report approval.
Head – Production:
➢ Review of protocol, the completed qualification data package, and the final
report approval.
➢ Assist in the resolving the validation deficiencies.
Head – Operation/ Quality Assurance:
➢ Review and approval of protocol, the completed qualification data package,
and the final report.
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2.5 Execution Team:

The satisfactory determination of pure steam quality shall be verified by executing

the studies described in this protocol. The successfully executed protocol
document indicates that the pure steam meet the predermined specification.

Execution team is responsible for the execution of verification study of pure steam
quality. All executors involved with this protocol shall sign within the prescribed
format given below:

NAME DEPARTMENT DESIGNATION SIGNATURE DATE

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_____________________ ____________________ 6 of 24

3.0 GENERAL CONSIDERATION / PREREQUISITE

3.1 The installation and operational qualification of the equipment shall be successfully
completed before the verification study of pure steam quality.

3.2 Approved standard operating procedure of the system shall be available.

3.3 Approved standard operating Procedure for each test (Non codensable gas, Degree
of super heat and dryness fraction test) shall be available.

3.4 All the deficiencies and discrepancies related to the system which affect the product
quality and corrective action taken shall be recorded in the appropriate section of the
protocol.

3.5 The test observation shall be recorded in the respective Annexure of the protocol and
finally verified.

4.0 RE-VERIFICATION STUDY CRITERIA:

The Pure steam condensate quality of generation and respective Autoclave sampling
point shall be re-verified through physical test, prior to re-validation of concern
autoclave in every six month.
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5.0 SYSTEM & PROCESS DESCRIPTION:

The Pure Steam Generation is system consists of single column with Evaporator &
Separator. The Evaporator is a shell & tube type of heat exchanger. The driving
force i.e. plant steam heats the feed water in the tube side of evaporator to generate
vapour. The generated vapour move to separator column. The separator column
uses a separation technique for particle entrainment. The multi-directional baffle,
which makes the vapour traverse a torturous path to ensure dry and saturated
steam.
GENERATION & DISTRIBUTION SYSTEM SAMPLING POINTS:
To provide the Pure Steam to the different user points in Generation & Distribution
system. User Points are as follows:

Sr. No. Sampling point No. Sampling points Description

1. PSC-01 Pure Steam Generator one point (SB)
2. PSC-02 Pure Steam Generator other point (WB)
3. PSC-03 Autoclave Line
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6.0 METHODOLOGY FOR VERIFICATION STUDY OF STEAM QUALITY:

Determination of pure steam condensate quality shall be done by through physical
test of steam (Non codensable gas, Degree of super heat and dryness fraction test) for all
sampling point for the period of one day.
6.1 PURE STEAM QUALITY TEST:
The pure steam generator and distributon line shall be verified for the quality by
folowing:
➢ Non condensable gas
➢ Degree of superheat test
➢ Dryness fraction test

6.1.1 Non condensable gas:

6.1.1.1 Objective:
The steam quality test, non-condensable gases is used to demonstrate that the level
of non-condensable gases contained in the steam will not prevent the attainment of
sterilization conditions in any part of the sterilizer load. EN 285:1997: 24.1

6.1.1.2 Sampling Procedure: At the time of sampling following test kit shall be required.
Test kit:
a. Burette bulb
b. Burette cock
c. Burette
d. Burette guide
e. Condense collection cylinder
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f. 250 ml measuring cylinder Non condensable take off

g. Steam condensing unit

Figure -1(Elbow)

Figure -2 (steam condensing unit)

Arrange the test kit as per respective user guide / SOP ( SOP No........................) and
start the sampling with the help of above arrangement and note down the volume of
gas and volume of condensate and calculate the non condensable gas value with the
help of following formula:

Non condensable =100 x (Vg/Vc)

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Where Vg is volume of gas and Vc is volume of condensate.

For example the Vg is 5.2 and Vc is 150 then the non condensable gas = 100 x
(5.2/150)
= 3.46% (within limit).

6.1.1.3 Acceptance criteria:

Non condensable gas is not more than 3.5% (as per EN-285 guideline)
6.1.1.4 Result evaluation:
The test result shall be evaluated as per attached annexure-I
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6.1.2 Degree of super heat test:

6.1.2.1 Objective:
The steam quality test, superheat is used to demonstrate that the amount of moisture
in suspension with steam supplied from the sterilizer service supply is sufficient to
prevent the steam from becoming superheated during expansion into the sterilizer
chamber. EN 285:1997: 24.3
6.1.2.2 Sampling Procedure: At the time of sampling following test kit shall be required.
Test kit: Pitot tube for super heat test

Figure-3 Figure -4 (Elbow)

Arrange the test kit as per respective user guide / SOP ( SOP No................) and
sampling shall be carried out with the help of above arrangement and note down the
temperature in expansion tube and calculate the degree of super heat test with the
help of following formula:

Degree of supper heat = Te – To

Where Te is temperature in expansion tube 0C and To is the boiling point of water at

local atmospheric pressure 0C.
For example Te = 109.4 and To = 99.6 then
Degree of super heat = 109.4 – 99.6 = 9.80C (within limit).
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6.1.3.3 Acceptance criteria

The degree of super heat test is less than 250C (as per EN-285 guideline)
6.1.3.4 Result evaluation:
The test result shall be evaluated as per attached annexure-II
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6.1.3 Dryness fraction test:

6.1.3.1 Objective:
A continuous supply of saturated steam is required for steam sterilization. Excess
moisture carried in suspension can cause damp loads, while too little cannot prevent
the steam from becoming superheated during expansion into the sterilizer chamber.
EN 285:1997: 24.2
6.1.3.2 Sampling Procedure: At the time of sampling following test kit shall be required.
Test Kit: Pitot tube for dryness fraction
heat test

Temperature sensor for dryness test

Figure -5 Figure -6 (Elbow)

Arrange the test kit as per respective user guide / SOP ( SOP No.......................) and
sampling shall be carried out with the help of above arrangement and note down the
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initial temperature of water in flask in 0C, final temperature of water and condensate in
flask in 0C, average temperature of steam delivered to sterilizer in 0C, Initial mass of
flask in kg, Initial mass of flask assembly and water in kg, final mass of flask
assembly, condensate and water in kg and latent heat of dry saturated steam at
temperature TA(KJ kg-1) {hfg from steam table} and calculate the dryness fraction
value with the help of this formula:

D = (Tf - Ts) ((4.18(Ms – Me)) + 0.24 - 4.18(Ta - Tf)

L (Mf – Ms) L

Where Ts = Initial temperature of water in flask in 0C

Tf = final temperature of water and condensate in flask in 0C
Ta = average temperature of steam delivered to sterilizer in 0C
Me = Initial mass of flask in kg
Ms = Initial mass of flask assembly and water in kg
Mf = final mass of flask assembly, condensate and water in kg
L = latent heat of dry saturated steam at temperature TA (KJ kg-1) {hfg from steam
table}
For example:
Me = 0.6, Ms = 1.232, Mf = 1.309, Ts = 19.0, Tf = 81.0, Ta = 144.0 and L = 2132
then,
D = (81-19) ((4.18(1.232-0.6))+0.24 - 4.18(144-81)
2132(1.309-1.232) 2132 = 0.964 (within limit).
6.1.4.3 Acceptance criteria
The Dryness fraction test value is > 0.90 (as per EN-285 guideline)
6.1.3.4 Result evaluation:
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The test result shall be evaluated as per attached annexure-III

7.0 ABBREVIATION:
SOP: Standard operating procedure

UTI : Utility

PSC : Pure Steam Condensate

PSG : Pure Steam Generator

EQI : Equipment
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8.0 LIST OF ANNEXURES:

Annexure No. Document Title

Remarks (if any):

__________________________________________________________________________

__________________________________________________________________________

Checked By Verified By
Sign & Date Sign & Date
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9.0 DEFICIENCY AND CORRECTIVE ACTION(S) REPORT(S)

Following deficiency was identified and corrective actions taken in consultation with the
validation team.

Description of Deficiency:

Corrective action(s) taken:

Deviation Accepted By Deviation Approved by

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Sign/Date Sign/Date
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10.0 PERFORMANCE QUALIFICATION SUMMARY AND CONCLUSION:

10.1 SUMMARY:

10.2 CONCLUSION:

Prepared By Checked By
(Sign/Date) (Sign/Date)
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11.0 FINAL REPORT APPROVAL:

It has been verified that all tests required by this Verification study protocol are completed,
reconciled and attached to this protocol or included in the verification study summary report.
Verified that all amendments and discrepancies (if applicable) are documented, approved
and attached to this protocol. Signature in the block below indicate that all items in this
verification report of Pure steam quality (through physical test i.e. Non condensable
gas,degree of Super heat & dryness fraction test) have been reviewed and found to be
acceptable and that all variations or discrepancies (if applicable) have been satisfactorily
resolved.

FUNCTION NAME DESIGNATION DEPARTMENT SIGNATURE DATE

QUALITY
ASSURANCE

ENGINEERING

REVIEWED
BY
QUALITY
CONTROL

PRODUCTION

HEAD
OPERATION
APPROVED
BY
QUALITY
ASSURANCE
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ANNEXURE – I
NON CONDENSABLE GAS TEST

Sr. No. Testing Parameter Observation

1. Date of testing

2. Sampling ID No

3. Sampling Location

4. Volume of gas (Vg)

5. Volume of condensate (Vc)

6. Acceptable Limit (%) <3.5%

7. Non condensable gases (%):

[100 x (Vg/Vc)]

8. Calculated by (Sign & Date)

Remarks (if any):

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

Checked By Verified By
Sign & Date Sign & Date
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_____________________ ____________________ 22 of 24

ANNEXURE – II
DEGREE OF SUPER HEAT TEST
Sr. No. Testing Parameter Observation

1. Date of testing

2. Sampling ID No

3. Sampling Location

4. Temperature in expansion tube (Te )0C

5. Boiling point of water at local

atmospheric pressure (To) 0C

6. Acceptable Limit (0C) <250C

7. Degree of Super Heat (0C): [Te – To]

8. Calculated by (Sign & Date)

Remarks (if any):

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

Checked By Verified By
Sign & Date Sign & Date
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ANNEXURE – III
DRYNESS FRACTION TEST
Sr. No. Testing Parameter Observation

9. Date of testing

10. Sampling ID No

11. Sampling Location

12. Initial temperature of water in flask in 0C (Ts)

13. Final temperature of water and condensate in flask in 0C

(Tf)

14. Average temperature of steam delivered to sterilizer in 0C

(Ta)

15. Initial mass of flask in kg (Me)

16. Initial mass of flask assembly and water in kg (Ms)

17. Final mass of flask assembly, condensate and water in

kg (Mf)

18. Latent heat of dry saturated steam at temperature TA(KJ

kg-1) {hfg from steam table} (L)

19. Acceptable Limit >0.90

Formula used for calculation:

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Dryness value (D) = (Tf - Ts)((4.18(Ms – Me)) + 0.24 - 4.18(Ta - Tf)

L(Mf – Ms) L

Sampling ID No: Sampling location:

D=( - )((4.18( - ))+0.24 – 4.18( - )

( - )

D= Calculated by (Sign & date) :

Remarks (if any):

__________________________________________________________________________

__________________________________________________________________________

__________________________________________________________________________

Checked By Verified By
Sign & Date Sign & Date